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Investigational New Drug Application for SPC2996, RNA Antagonist, Approved by FDA

COPENHAGEN, Denmark, November 8/PRNewswire/ -- Santaris Pharma, the Danish biopharmaceutical company developing innovative RNA-silencing drugs for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug Application (IND) for the Company's international Phase I/II study of SPC2996 in Chronic Lymphocytic Leukaemia (CLL).

SPC2996 is the first of a new class of LNA-based investigational drugs known as RNA Antagonists and is designed to reduce the level of Bcl-2 protein within tumor cells by binding and inactivating Bcl-2 messenger RNA, thereby inducing programmed cell death (apoptosis). Bcl-2 is highly over-expressed in CLL cells and appears to play a role in pathogenesis of the disease, preventing lymphocyte apoptosis and being strongly correlated with poor clinical outcome.

The Phase I/II clinical trial, the European arm of which is already ongoing in Denmark, UK and France, is an open-label, escalating, repeated-dose, multi-center study of SPC2996 in patients with relapsed or refractory CLL requiring therapy. The primary objective is to investigate the safety and potential efficacy of SPC2996 in CLL patients and the Company plans to enrol an overall total of 42 patients. The participation of US centers is intended to facilitate the further development of this novel investigational agent.

Lene Worsaae Dalby, Vice-President of Clinical Development at Santaris Pharma, commented:

"The FDA approved the SPC2996 dossier as submitted and without questions. To receive IND approval is always pleasing, but to obtain approval for the first IND for a new class of molecule without any regulatory issues or concerns is particularly gratifying and reflects the dedication and skill of the team at Santaris."

The first US center to join the study will be the Holden Comprehensive Cancer Center at the University of Iowa where the trial will be under the direction of Dr. James Wooldridge.

Source: Santaris Pharma

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